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To America's Health: A Proposal to Reform the Food and Drug Administration (Hoover Institution Press Publication) Paperback – August 1, 2000

ISBN-13: 978-0817999025 ISBN-10: 0817999027 Edition: First Edition

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Product Details

  • Series: Hoover Institution Press Publication (Book 482)
  • Paperback: 112 pages
  • Publisher: Hoover Institution Press; First Edition edition (August 1, 2000)
  • Language: English
  • ISBN-10: 0817999027
  • ISBN-13: 978-0817999025
  • Product Dimensions: 0.5 x 6 x 8.8 inches
  • Shipping Weight: 9.1 ounces (View shipping rates and policies)
  • Average Customer Review: 1.5 out of 5 stars  See all reviews (2 customer reviews)
  • Amazon Best Sellers Rank: #3,727,586 in Books (See Top 100 in Books)

Editorial Reviews

Review

"Extraordinary for its depth, documentation, and originality. In terms of analyzing the current system of drug regulation, making the case for reform, and proposing a remedy, this volume simply dwarfs everything else available on the subject. Most important of all, it really does move us along the path 'To America's Health!'"

- Michael H. Mellon, M.D., Associate Clinical Professor, Pediatrics, University of California, San Diego, School of Medicine, La Jolla, CA

From the Publisher

A government monopoly over drug regulation is not sacrosanct. In fact, federal oversight--which vitally affects the availability of drugs to patients in need--is a shambles. The regulatory monopoly of the federal Food and Drug Administration has become, literally, overkill and actually threatens public health. Regulatory reform that introduces competition and incentives to get safe, effective drugs to patients can, however, transform the drug development process and reverse the current upward spiral of time and costs. The public will benefit directly by earlier access to greater numbers of less costly drugs and indirectly by greater robustness and productivity in the pharmaceutical industry.

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3 of 5 people found the following review helpful By achamblee on November 20, 2004
Format: Paperback
Henry Miller is a fellow at the Hoover Institute at Stanford University. The articles he posts there are something that my undergrad logic teacher would have to flunk. (Example: If (A) there are drugs in the pipeline, and if (B) FDA must review data to show drugs are safe and effective, then (c) FDA's unreasonable review is the only thing stopping all drugs in the pipeline from working; therefore all drugs should be mass-marketed to human guinea pigs or else people will die from lack of access to drugs.) The conclusion is not supported by his premises, a problem in all Miller's writings. He also ignores history, failing to mention the kind of junk that was sold as cures before FDA came along. In fact the agency was established when the public insisted. Responsible manufacturers joined, struggling with dozens of different state laws and with disreputable competition undercutting them, counterfeiting their products, and selling products contaminated with filth, cheap fillers, and unintended cross-contamination from other ingredients made in the same facilities.

The truth is, there are lots of programs to get drugs, approved or not, to sick people. If only drug companies would manufacture them instead of the many kinds of "me, too" drugs with huge mark-ups, those drugs might be available. However, FDA can't review drugs that no one makes. FDA drug review takes on average barely more than 6 months despite volumes of data, and since someone has to review the data, anyway, that's not much real added time. And aren't you glad it's not drug company marketing departments doing the medical reviews? Peer review journals easily take that long to review the articles of studies submitted to them.

This is not to say FDA is perfect, always right, or no reform is needed.
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8 of 13 people found the following review helpful By A Customer on August 20, 2003
Format: Paperback
While it may be true that some reform at the FDA is needed, the way this book portrays the problem is seriously flawed. This is surprising as it comes from a guy that actually worked at the FDA. The book is filled with number fudging, half truths and ridiculous distortions. For example, the book cited that the FDA raised the bar for clinical research that resulted in the time required for drug development to increase from 8.1 years to 15.2 years from 1960s to 1997 (Page 24). Why is that bad? Remember the law that requires a drug to be effective was only passed in 1962. Back then, a scientifically sound clinical study for effectiveness wasn't even defined. As the science progresses, the bar has to be raised. Moreover, a lot of drugs nowadays have to be taken for years (for example, statin drugs). The only way to know the long term safety of these drugs is to do long term study. Hence, long time required for clinical studies. Even with this kind of rigor, there are still drugs like Baycol out there harming people. In another place, the author quoted that the number of safety discontinuations as a percentage of total new drug introductions in each country were similar - about 4 percent in UK and 3 percent in US. The author thus concluded that a marketed drug will be removed from the market is not appreciable different in the UK and US (page 27). This is number fudging at its best. Sure, 4% and 3% are all small numbers. But 4%/3% is 1.33. That means UK approves 33% more harmful drugs than US. No wonder the FDA is viewed as the "gold standard."
I highly recommened a report by Public Citizen on the brandname drug industry. When people see how profitable they are and how little they actually devote to research, they won't believe all this whining on behalf of these companies.
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To America's Health: A Proposal to Reform the Food and Drug Administration (Hoover Institution Press Publication)
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